Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The United States Patent & Trademark Office appreciates the application that is submitted by the inventor/assignee. The United States Patent & Trademark Office reviewed the following application and has made the following comments below.
Priority
This application claims benefit of foreign priority under 35 U.S.C. 119(a)-(d) of JP-2023214791 , filed in Japan on 12/20/2023.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4, 8-10, 12-15 are rejected under 35 U.S.C 103 as being anticipated by Bang et al (U.S. Patent Pub. No 2021/0393212 A1, hereinafter referred to as Bang) in view of Dahdouh (U.S. Patent Pub. No 2024/0144472-A1, hereinafter referred to as Dahdouh)
In regards to claim 1, Bang teaches a medical image processing apparatus comprising processing circuitry configured to: acquire a first medical image collected by predetermined imaging on an imaging site of a subject (paragraph 43, Bang discloses acquiring a first medical image by predetermined imaging of a brain) and a second medical image collected by imaging different from the predetermined imaging and including the imaging site (paragraph 44, Bang discloses obtaining a second medical image of the brain by imaging different from the predetermined imaging); in the second medical image (paragraph 44, Bang discloses obtaining a second medical image) decide, as the second area, an area corresponding to line symmetry of the first area with a center line relative to the imaging site as a symmetry axis (paragraph 64, Figure 7, Bang discloses identifying an area corresponding to the symmetric area with a center line relative to the brain, examiner interprets this as an area corresponding to the line of symmetry with a center line relative to the imaging site as a symmetry axis) in the second medical image (paragraph 44, Bang discloses obtaining a second medical image) (paragraph 111-117, Bang discloses calculating a feature amount based on the first region in the second image) and a second feature amount indicating a feature based on a plurality of pixel values in the second area (paragraph 111-117, Bang discloses calculating a second feature amount based on the second region, in the second image), and calculate an index related to a mismatch between the first medical image and the second medical image, (paragraph 138, Bang discloses calculating a degree of mismatch between two medical images) based on the first feature amount and the second feature amount (paragraph 138, Bang discloses determining the mismatch value based on feature amounts of each region).
Bang does not explicitly disclose identify a first area related to a lesion in the imaging site, based on the first medical image; determine whether the first is bilateral or unilateral with respect to the imaging, based on a position of the first area in the imaging site; decide an area different from the first area in the second medical image as a second area indicating a normal portion in the imaging site in a case where it is determined that the first area is bilateral and
Dahdouh is in the same field of the art of quantitatively evaluating lesions in the brain. Further, Dahdouh teaches identify a first area related to a lesion in the imaging site, based on the first medical image (paragraph 137, paragraph 138, Dahdouh discloses identifying a first region in the first image that is a lesion); determine whether the first area (paragraph 137, paragraph 138, Dahdouh discloses a first region) is bilateral or unilateral with respect to the imaging site (paragraph 125, Dahdouh discloses identifying if the lesion region spans both hemispheres), based on a position of the first area in the imaging site (paragraph 125, Dahdouh discloses determining lesion location is based on the position of the patch in the two hemispheres of the brain); decide an area different from the first area (paragraph 127, Dahdouh discloses deciding an area different from the first area) in the second medical image as a second area indicating a normal portion (paragraph 85, Dahdouh discloses indicating healthy tissue In the atlases) in the imaging site in a case where it is determined that the first area is bilateral (paragraph 126, Dahdouh discloses a condition where an lesion rests in both hemispheres of the brain, examiner interprets this as bilateral lesion) in a case where it is determined that the first area is unilateral (paragraph 126, Dahdouh discloses a condition where an lesion rests in only one hemisphere of the brain, examiner interprets this as unilateral lesion).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bang by modifying the medical processing apparatus in Bang to identify a first area related to a lesion, determine whether the first area is bilateral or unilateral with respect to the imaging site, decide a second area indicating a normal position when the first area is bilateral taught by Dahdouh and modifying the process of selecting a second area corresponding to a line of symmetry to the first area with a center line relative to the imaging site as asymmetry axis in the second image in Bang by applying it in case where the first area is unilateral taught in Dahdouh, to make the invention that uses a the medical processing apparatus (Bang) to identify a first area related to a lesion in the first image, determine if the a first area is unilateral or bilateral, select a second area indicating a normal position when the first area is bilateral (Dahdouh) and uses symmetric area selection process (Bang) when the first area is unilateral (Dahdouh); thus, one of ordinary skill in the art would be motivated to combine the references since producing high-quality annotated datasets for training may require a large amount of labor and specific domain knowledge in medical imaging (paragraph 3, Dahdouh).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
In regards to claim 2, Bang in view of Dahdouh discloses wherein, the first medical image and the second medical image are axial sections of the imaging site or coronal sections of the imaging site (Figure 7, Bang discloses a first and a second medical image that are axial sections of the brain, where axial sections of the brain divide the brain into a horizontal cross section where the two hemispheres of the brain are symmetrical, see illustration below).
PNG
media_image1.png
406
460
media_image1.png
Greyscale
In regards to claim 3, Bang in view of Dahdouh discloses wherein, the first medical image is a diffusion weighted image (paragraph 18, paragraph 43, Bang discloses a diffusion weighted image), and wherein the second medical image is a fluid attenuated inversion recovery (FLAIR) image (paragraph 59, Bang discloses a fluid attenuated inversion recovery image).
In regards to claim 4, Bang in view of Dahdouh discloses wherein, the first feature amount is a statistical value (paragraph 111-116, Bang discloses a feature amount that is a statistical value) based on a plurality of pixel values included in the first area (paragraph 111-116, Bang discloses calculating a feature amount based on the first region data), and wherein the second feature amount is a statistical value (paragraph 111-116, Bang discloses calculating a feature amount based on the first region in the second image) based on a plurality of pixel values included in the second area (paragraph 111-116, Bang discloses calculating a feature amount based on the second region in the second image).
In regards to claim 8, Bang in view of Dahdouh discloses wherein, the processing circuitry determines whether or not the first area is included in an anatomic site (paragraph 124, Dahdouh teaches a region that is included in an anatomic site, examiner interprets opposite hemisphere as a anatomic site) located across a center line relative to the imaging site (Figure 7, Bang teaches a center line relative to the imaging site), and determines that the first area is bilateral when the first area is included in the anatomic site (paragraph 127, Dahdouh teaches determining a bilateral area when the area is included in the anatomic site), and determines that the first area is unilateral in a case where the first area is not included in the anatomic site (paragraph 126, Dahdouh teaches determining a unilateral area when the area is not included in the anatomic site)
In regards to claim 9, Bang in view of Dahdouh discloses wherein, the processing circuitry identifies the anatomic site by performing predetermined image processing (paragraph 86, Dahdouh teaches performing predetermined image processing on medical images for a feature of interest in an anatomical region, examiner interprets the process must identify an anatomic region in order to perform processing on features in the region) on the second medical image (paragraph 44, Bang discloses obtaining a second medical image of the brain by imaging different from the predetermined imaging).
In regards to claim 10, Bang in view of Dahdouh teaches wherein, in a case where it is determined that the first area is bilateral (paragraph 127, Dahdouh teaches a condition where the lesion rests in both hemispheres of the brain, the processing circuitry decides an area having an apparent diffusion coefficient that exceeds a predetermined value (paragraph 120, paragraph 124, Bang teaches deciding an area having an apparent diffusion coefficient that exceeds a predetermined value) as the second area (paragraph 127, Dahdouh teaches selecting a second region in a case where the first area bilateral).
In regards to claim 12, Bang in view of Dahdouh discloses wherein, in a case where the first area is determined to be bilateral (paragraph 127, Dahdouh teaches a condition where the lesion rests in both hemispheres of the brain), the processing circuitry decides an area similar to a property of tissue (paragraph 122, Dahdouh teaches using anatomical information of tissue) in the first area as the second area (paragraph 127, Dahdouh teaches selecting a second region a corresponding patch to the first area).
In regards to claim 13, Bang in view of Dahdouh discloses wherein, further comprising a display (paragraph 83, Bang teaches a display unit) configured to superimpose the first area and the second area on the second medical image together with the index (paragraph 83, Figure 8, Bang teaches superimposing a first area and a second area on the second medical image with a value, see illustration below).
PNG
media_image2.png
482
661
media_image2.png
Greyscale
In regards to claim 14, Bang teaches a medical image processing method comprising: acquiring a first medical image collected by predetermined imaging on an imaging site of a subject (paragraph 43, Bang discloses acquiring a first medical image by predetermined imaging of a brain) and a second medical image collected by imaging different from the predetermined imaging and including the imaging site (paragraph 44, Bang discloses obtaining a second medical image of the brain by imaging different from the predetermined imaging(paragraph 44, Bang discloses obtaining a second medical image) (paragraph 64, Figure 7, Bang discloses identifying an area corresponding to the symmetric area with a center line relative to the brain, examiner interprets this as an area corresponding to the line of symmetry with a center line relative to the imaging site as a symmetry axis) in the second medical image (paragraph 44, Bang discloses obtaining a second medical image) (paragraph 111-117, Bang discloses calculating a feature amount based on the first region in the second image) and a second feature amount indicating a feature based on a plurality of pixel values in the second area (paragraph 111-117, Bang discloses calculating a second feature amount based on the second region, in the second image); and calculating an index related to a mismatch between the first medical image and the second medical image (paragraph 138, Bang discloses calculating a degree of mismatch between two medical images), based on the first feature amount and the second feature amount (paragraph 138, Bang discloses determining the mismatch value based on feature amounts of each region).
Bang does not explicitly disclose identifying a first area related to a lesion in the imaging site, based on the first medical image; determining whether the first area is bilateral or unilateral with respect to the imaging site, based on a position of the first area in the imaging site; deciding an area different from the first area in the second medical image as a second area indicating a normal portion in the imaging site in a case where it is determined that the first area is bilateral;
Dahdouh is in the same field of the art of quantitatively evaluating lesions in the brain. Further, Dahdouh teaches identifying a first area related to a lesion in the imaging site, based on the first medical image (paragraph 137, paragraph 138, Dahdouh discloses identifying a first region in the first image that is a lesion); determining whether the first area (paragraph 137, paragraph 138, Dahdouh discloses a first region) is bilateral or unilateral with respect to the imaging site (paragraph 125, Dahdouh discloses identifying if the lesion region spans both hemispheres), based on a position of the first area in the imaging site (paragraph 125, Dahdouh discloses determining lesion location is based on the position of the patch in the two hemispheres of the brain); deciding an area different from the first area (paragraph 127, Dahdouh discloses deciding an area different from the first area) in the second medical image as a second area indicating a normal portion (paragraph 127, Dahdouh discloses deciding an area different from the first area) in the imaging site in a case where it is determined that the first area is bilateral (paragraph 126, Dahdouh discloses a condition where an lesion rests in both hemispheres of the brain, examiner interprets this as bilateral lesion); (paragraph 126, Dahdouh discloses a condition where an lesion rests in only one hemisphere of the brain, examiner interprets this as unilateral lesion).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bang by modifying the medical processing apparatus in Bang to identify a first area related to a lesion, determine whether the first area is bilateral or unilateral with respect to the imaging site, decide a second area indicating a normal position when the first area is bilateral taught by Dahdouh and modifying the process of selecting a second area corresponding to a line of symmetry to the first area with a center line relative to the imaging site as asymmetry axis in the second image in Bang by applying it in case where the first area is unilateral taught in Dahdouh, to make the invention that uses a the medical processing apparatus (Bang) to identify a first area related to a lesion in the first image, determine if the a first area is unilateral or bilateral, select a second area indicating a normal position when the first area is bilateral (Dahdouh) and uses symmetric area selection process (Bang) when the first area is unilateral (Dahdouh); thus, one of ordinary skill in the art would be motivated to combine the references since producing high-quality annotated datasets for training may require a large amount of labor and specific domain knowledge in medical imaging (paragraph 3, Dahdouh).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
In regards to claim 15, Bang teaches a non-transitory computer-readable storage medium storing a medical image processing program for causing a computer to: acquire a first medical image collected by predetermined imaging on an imaging site of a subject (paragraph 43, Bang discloses acquiring a first medical image by predetermined imaging of a brain) and a second medical image collected by imaging different from the predetermined imaging and including the imaging site (paragraph 44, Bang discloses obtaining a second medical image of the brain by imaging different from the predetermined imaging); (paragraph 44, Bang discloses obtaining a second medical image of the brain by imaging different from the predetermined imaging) (paragraph 64, Figure 7, Bang discloses identifying an area corresponding to the symmetric area with a center line relative to the brain, examiner interprets this as an area corresponding to the line of symmetry with a center line relative to the imaging site as a symmetry axis) in the second medical image (paragraph 44, Bang discloses obtaining a second medical image) (paragraph 111-117, Bang discloses calculating a feature amount based on the first region in the second image) and a second feature amount indicating a feature based on a plurality of pixel values in the second area (paragraph 111-117, Bang discloses calculating a second feature amount based on the second region, in the second image); and calculate an index related to a mismatch between the first medical image and the second medical image (paragraph 138, Bang discloses calculating a degree of mismatch between two medical images), based on the first feature amount and the second feature amount (paragraph 138, Bang discloses determining the mismatch value based on feature amounts of each region).
Bang does not explicitly disclose identify a first area related to a lesion in the imaging site, based on the first medical image; determine whether the first area is bilateral or unilateral with respect to the imaging site, based on a position of the first area in the imaging site; decide an area different from the first area
Dahdouh is in the same field of the art of quantitatively evaluating lesions in the brain. Further, Dahdouh teaches identify a first area related to a lesion in the imaging site, based on the first medical image (paragraph 137, paragraph 138, Dahdouh discloses identifying a first region in the first image that is a lesion); determine whether the first area (paragraph 137, paragraph 138, Dahdouh discloses a first region) is bilateral or unilateral with respect to the imaging site (paragraph 125, Dahdouh discloses identifying if the lesion region spans both hemispheres), based on a position of the first area in the imaging site (paragraph 125, Dahdouh discloses determining lesion location is based on the position of the patch in the two hemispheres of the brain); decide an area different from the first area (paragraph 127, Dahdouh discloses deciding an area different from the first area) (paragraph 85, Dahdouh discloses indicating healthy tissue In the atlases) in the imaging site in a case where it is determined that the first area is bilateral (paragraph 126, Dahdouh discloses a condition where an lesion rests in both hemispheres of the brain, examiner interprets this as bilateral lesion); in a case where it is determined that the first area is unilateral (paragraph 126, Dahdouh discloses a condition where an lesion rests in only one hemisphere of the brain, examiner interprets this as unilateral lesion).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bang by modifying the medical processing apparatus in Bang to identify a first area related to a lesion, determine whether the first area is bilateral or unilateral with respect to the imaging site, decide a second area indicating a normal position when the first area is bilateral taught by Dahdouh and modifying the process of selecting a second area corresponding to a line of symmetry to the first area with a center line relative to the imaging site as asymmetry axis in the second image in Bang by applying it in case where the first area is unilateral taught in Dahdouh, to make the invention that uses a the medical processing apparatus (Bang) to identify a first area related to a lesion in the first image, determine if the a first area is unilateral or bilateral, select a second area indicating a normal position when the first area is bilateral (Dahdouh) and uses symmetric area selection process (Bang) when the first area is unilateral (Dahdouh); thus, one of ordinary skill in the art would be motivated to combine the references since producing high-quality annotated datasets for training may require a large amount of labor and specific domain knowledge in medical imaging (paragraph 3, Dahdouh).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Claim(s) 5 are rejected under 35 U.S.C 103 as being anticipated by Bang et al (U.S. Patent Pub. No 2021/0393212 A1, hereinafter referred to as Bang) in view of Dahdouh (U.S. Patent Pub. No 2024/0144472-A1, hereinafter referred to as Dahdouh) and further in view of Goto et al (U.S Patent Pub. No 2023/0316517 A1, hereinafter, referred to as Goto).
In regards to claim 5, Bang in view of Dahdouh teaches the medical image processing apparatus of claim 1 that calculates an index related to a mismatch between the first medical image and the second medical image, based on the first feature amount and the second feature amount.
Bang in view of Dahdouh does not explicitly teach wherein, the index is a ratio between the first feature amount and the second feature amount.
Goto is in the same field of the art of quantitatively evaluating regions in an anatomical structure.
Further, Goto teaches wherein the index is a ratio between the first feature amount and the second feature amount (paragraph 63, Goto teaches determining a ratio based on a first feature amount and a second feature amount).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the invention of Bang in view of Dahdouh by modifying the index taught by Bang in view of Dahdouh to be a ratio based on a first and a second feature taught by Goto to make the invention that calculates a index (Bang in view of Dahdouh) that is a ratio (Goto); Thus one of ordinary skill in the art would be motivated to combine the references since by analyzing regions in medical images, it is possible to easily determine the degree of disease (Goto, paragraph 4).
Allowable Subject Matter
Claim 6 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 7 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 11 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 6 and 7 are objected to since no prior art teach determining the first area as bilateral in a case where a first area overlaps with a symmetric area corresponding to line symmetry of the first area with a center line relative to the imaging site as a symmetry axis.
Claim 11 is objected to since no prior art teaches deciding a second area that does not include cerebral spinal fluid of the subject and an area outside of the brain.
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to the applicant’s disclosure
Larson et al U.S. Patent Publication No. 20230410301
Nagenthiraja et al U.S. Patent Publication No. 20130266197
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ANTHONY DAVIS whose telephone number is (571)272-0170. The examiner can normally be reached M-F 7:30am-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Oneal Mistry can be reached at (313)446-4912. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL ANTHONY DAVIS III/Examiner, Art Unit 2674
/ONEAL R MISTRY/Supervisory Patent Examiner, Art Unit 2674
